# FDA 483 - Fertility Center of Southern California - March 14, 2025

Source: https://www.keypedia.com/records/483/fertility-center-of-southern-california/202a2f76-ec1a-44b2-8a21-10fa7c5de9a1

> FDA 483 for Fertility Center of Southern California on March 14, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fertility Center of Southern California
- Inspection Date: 2025-03-14
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Fertility Center of Southern California in Irvine, CA, from March 11-14, 2025. The inspection revealed a significant issue where a human cell, tissue, or cellular and tissue-based product (HCT/P) donor with a known risk factor for Creutzfeldt-Jacob Disease was improperly determined eligible, leading to the donation and cryopreservation of oocytes and tissues. This indicates a serious lapse in donor eligibility determination processes.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/fertility-center-of-southern-california/9f80a61e-7d19-4bd9-ad9c-2a8caf1404a4)

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/fertility-center-of-southern-california/6138ad04-0569-4ded-a869-ee47332b5bfd

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6